Job Type: Contract
Contract Length: 8 months
Pay Range: $50-55/hr
Start Date: ASAP
Location: Remote - East Coast strongly preferred (ideally someone who is able to drive to Maine, if needed in the future)
About the Opportunity:
Our client, a leader in Healthcare, is looking for a skilled eQMS Quality Lead to join their team for an 8-month engagement. This project involves providing hands-on support for validation testing of an enterprise Quality Management System (QMS), ensuring the system is validated, compliant, and fit for use in a regulated environment. This is a high-impact role that requires a self-motivated professional who can hit the ground running and deliver results quickly.
Key Responsibilities & Deliverables:
This role is focused on the successful completion of specific tasks and deliverables. Your responsibilities will include:
- Lead requirements-based validation of QMS functionality, including the development and execution of Functional Requirements Specifications (FRS) and Operational Qualification (OQ) test cases.
- Execute validation activities (e.g., OQ/PQ), perform risk-based testing, and produce complete, audit-ready validation documentation and execution evidence.
- Plan and execute integration testing between the QMS and connected enterprise systems (e.g., ERP, HR, training, or document repositories).
- Support internal and external audits by providing validation documentation, test evidence, and subject-matter expertise.
- Partner with Quality, IT, Regulatory, and Business stakeholders to ensure QMS solutions meet compliance, usability, and scalability needs.
We are looking for someone with a proven track record of successful contract engagements. The ideal candidate will have:
- Demonstrated experience testing or validating regulated systems, such as a Quality Management System (QMS).
- Deep expertise in QMS testing, Validation and Documentation Discipline, and strong knowledge of requirements-based testing and traceability.
- Experience creating and executing formal test cases with documented evidence.
- Familiarity with audit and inspection expectations for computerized systems.
- Strong communication skills with the ability to translate regulatory and quality expectations into practical testing strategies.
- Demonstrated ability to work autonomously and manage your own time effectively to meet project goals.
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